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mTOR inhibitor
Sirolimus for Post-COVID Fibrosis Prevention
Phase 2 & 3
Recruiting
Led By Ayodeji Adegunsoye, MD, MS
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Requiring supplemental oxygen ≥ 5LNC or ≥ 40% FiO2
Hospitalized
Must not have
History of unstable or deteriorating neurologic disease (including TIAs or stroke)
Clinical features or known diagnosis of malignancy or active non-COVID-19 infection, including untreated latent tuberculosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 84 days
Awards & highlights
Summary
This trialseeks to find out if a drug can stop COVID-19 pneumonia from leading to lung scarring.
Who is the study for?
Adults over 18 with COVID-19 pneumonia, needing oxygen support, and showing less than 10% lung fibrosis on a CT scan can join. They must be hospitalized, able to consent or have someone who can for them. Those with recent severe heart issues, sirolimus allergies, other serious health conditions, or women who are pregnant/lactating cannot participate.
What is being tested?
The trial is testing if Sirolimus can prevent lung scarring (pulmonary fibrosis) in patients hospitalized with COVID-19 pneumonia. It aims to see whether this drug reduces the chances of developing long-term lung damage after recovery from the virus.
What are the potential side effects?
Sirolimus may cause side effects like mouth sores, increased cholesterol levels, rash, diarrhea and lower blood cell counts which could raise infection risk. There might also be risks related to liver function changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need extra oxygen of at least 5 liters per minute or 40% oxygen concentration.
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I am currently in the hospital.
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I have been diagnosed with COVID-19 pneumonia.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had worsening or unstable brain or nerve conditions.
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I have cancer or an active infection that is not COVID-19, including untreated TB.
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I have not had serious heart problems or treatments in the last 6 months.
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I have been diagnosed with pulmonary fibrosis or interstitial lung disease.
Select...
I am not taking drugs that strongly affect liver enzyme CYP3A4.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 84 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~84 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Prevalence of Pulmonary Fibrosis as evidenced by CT scan
Secondary study objectives
10% Threshold for Pulmonary Fibrosis evidenced by CT scan
Duration of Increased Supplemental Oxygen from Baseline
Pulmonary Function Test impairment
+2 moreOther study objectives
Safety - Rate of Liver Function Test abnormalities
Trial Design
3Treatment groups
Active Control
Group I: Sirolimus 0.5mgActive Control1 Intervention
Subject will take Sirolimus 0.5mg orally daily for 14 days.
Group II: Sirolimus 1mgActive Control1 Intervention
Subject will take Sirolimus 1mg orally daily for 14 days.
Group III: Sirolimus 2mgActive Control1 Intervention
Subject will take Sirolimus 2mg orally daily for 14 days.
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,034 Previous Clinical Trials
753,634 Total Patients Enrolled
Ayodeji Adegunsoye, MD, MSPrincipal InvestigatorUniversity of Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your chest CT scan shows less than 10% lung scarring.I have not had worsening or unstable brain or nerve conditions.I have cancer or an active infection that is not COVID-19, including untreated TB.I have not had serious heart problems or treatments in the last 6 months.I am not pregnant or breastfeeding and will use birth control during the trial.I need extra oxygen of at least 5 liters per minute or 40% oxygen concentration.I can sign the consent form myself or have someone legally authorized to do so.I am currently in the hospital.I have been diagnosed with pulmonary fibrosis or interstitial lung disease.You have had a bad reaction to sirolimus in the past.You have a positive test for an active COVID-19 infection.I am 18 years old or older.I have been diagnosed with COVID-19 pneumonia.I am not taking drugs that strongly affect liver enzyme CYP3A4.
Research Study Groups:
This trial has the following groups:- Group 1: Sirolimus 0.5mg
- Group 2: Sirolimus 1mg
- Group 3: Sirolimus 2mg
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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